Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
NCT02073812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2018-03-05
Summary
RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
RPX7009 and RPX2014
The study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)
Sponsors & Collaborators
-
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
lead INDUSTRY
Principal Investigators
-
Mark Gotfried, MD · Pulmonary Associates
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- United States
Study Locations
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